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Diss Factsheets
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EC number: 500-109-8 | CAS number: 43011-20-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 021 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- adequate
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The registered substance is a member of the Selected Cyclic Acid Anhydrides category. The required registration data on reproductive toxicity is provided by a category member, phthalic acid. In a teratology study by Ema et al., 1997, phthalic acid did not cause reproductive or developmental toxicity in rats when administered during the organogenesis period of gestation. In support of a lack of targeted reproductive toxicity, expert groups at the WHO, 2009, reviewed the available repeated dose toxicity studies of several cyclic acid anhydrides, and concluded that systemic and reproductive toxicities are not observed. There is no evidence in repeated dose toxicity studies of adverse histopathological effects in reproductive or endocrine organs. Toxicokinetic behaviour favors rapid conversion of anhydrides to the acid form and subsequent urinary excretion. Reproductive toxicity is not one of the critical health effects of exposure to cyclic acid anhydride.
The category of cyclic acid anhydrides is based on the member having similar chemical behaviour and analogous breakdown products in environmental and biological systems. The common functional group is a 1,3-dioxo-1,3-dihydro-2-furan ring (i. e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario. The read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.Short description of key information:
Members of the Selected Cyclic Acid Anhydrides category are not reproductive or developmental toxicants.
Justification for selection of Effect on fertility via oral route:
experimental data on a member of the Selected Cyclic Acid Anhydrides category
Effects on developmental toxicity
Description of key information
Members of the Selected Cyclic Acid Anhydrides category are not reproductive or developmental toxicants.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 763 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- adequate
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The registered substance is a member of the Selected Cyclic Acid Anhydrides category. The required registration data on reproductive toxicity is provided by a category member, phthalic acid. In a teratology study by Ema et al., 1997, phthalic acid did not cause reproductive or developmental toxicity in rats when administered during the organogenesis period of gestation. In support of a lack of targeted reproductive toxicity, expert groups at the WHO, 2009, reviewed the available repeated dose toxicity studies of several cyclic acid anhydrides, and concluded that systemic and reproductive toxicities are not observed. There is no evidence in repeated dose toxicity studies of adverse histopathological effects in reproductive or endocrine organs. Toxicokinetic behaviour favors rapid conversion of anhydrides to the acid form and subsequent urinary excretion. Reproductive toxicity is not one of the critical health effects of exposure to cyclic acid anhydride.
The category of cyclic acid anhydrides is based on the member having similar chemical behaviour and analogous breakdown products in environmental and biological systems. The common functional group is a 1,3-dioxo-1,3-dihydro-2-furan ring (i. e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario. The read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.Justification for selection of Effect on developmental toxicity: via oral route:
experimental data on a member of the Selected Cyclic Acid Anhydrides category
Justification for classification or non-classification
There is no evidence of reproductive toxicity of members of the selected cyclic acid anhydrides category. The criteria for classification for reproductive toxicity in Regulation EC No. 1272/2008 are not met.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.